CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
ATM-AVI +1 moredrug
Likely dose
ATM-AVI 50 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02655419
NCT02655419Phase 2Completed
CompareCT.gov

A PHASE IIA PROSPECTIVE, OPEN-LABEL, MULTICENTER STUDY TO DETERMINE THE PHARMACOKINETICS (PK) AND SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) FOR THE TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAIS) IN HOSPITALIZED ADULTS

Pfizer·interventional·Posted Jan 14, 2016·Updated Apr 2, 2020

In Brief

A Phase 2 clinical trial evaluating ATM-AVI and Metronidazole for Complicated Intra-Abdominal Infections, cIAIs. Completed, enrolled 40 participants across 11 sites in 3 countries.

Detailed Summary

Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-Abdominal Infections, cIAIs
CountriesFrance, Germany, Spain
CollaboratorsInnovative Medicines Initiative

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 14, 2016
Enrollment StartMay 19, 2016
Primary CompletionOct 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.5 years ago

Interventions

ATM-AVIdrug

Cohort 1: (Creatinine clearance \> 50 mL/min)6500mg ATM/1777mg AVI on day 1 followed by total daily dose of 6000mg ATM/1640mg AVI Cohorts 2 and 3: (Creatinine clearance \> 50 mL/min) As above, or: 6500 mg ATM/2167 mg on Day 1 followed by a total daily dose of 6000 mg ATM/2000 m AVI (Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1162 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/820 mg AVI, or: 4250 mg ATM/1417 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/1000 mg AVI

Metronidazoledrug

Metronidazole 500mg infused over 1 hour every 8 hours